SPONSOR RESOURCES
SPONSOR RESOURCES
ABOUT PANONCOLOGY TRIALS
JIT Site | Central IRB | |
5 investigators | Private |
ABOUT PANONCOLOGY TRIALS
JIT Site | Central IRB | |
5 investigators | Private |
SITE INFORMATION
Has ever been audited by the FDA? | No |
Contracts with another company (SMO, etc.) to conduct clinical trials? | No |
SITE INFORMATION
Has ever been audited by the FDA? | No | ||||||||||||||||||
Contracts with another company (SMO, etc.) to conduct clinical trials? | No | ||||||||||||||||||
PATIENT RECORDS
Paper-based records stored in a secured location | Yes |
Secure, password protected, HIPAA and Part 11 compliant computer-based files are used | Yes |
Prior to access of PHI, site personnel and any visitors sign confidentiality statements agreeing to protect PHI | Yes |
PHI identifiers are removed/obliterated from study-related information | Yes |
Personnel receive documented HIPAA training | Yes |
Research patients are notified of the HIPAA rights prior to any procedures being performed | Yes |
PATIENT RECORDS
Paper-based records stored in a secured location | Yes |
Secure, password protected, HIPAA and Part 11 compliant computer-based files are used | Yes |
Prior to access of PHI, site personnel and any visitors sign confidentiality statements agreeing to protect PHI | Yes |
PHI identifiers are removed/obliterated from study-related information | Yes |
Personnel receive documented HIPAA training | Yes |
Research patients are notified of the HIPAA rights prior to any procedures being performed | Yes |
STUDY PRE-SCREENING / RECRUITMENT METHODS
Will you enroll any non-English speaking patients? | Yes |
STUDY PRE-SCREENING / RECRUITMENT METHODS
Will you enroll any non-English speaking patients? | Yes |
DRUG STORAGE, HANDLING, & ACCOUNTABILITY
-70C Freezer
Has -70C Freezer On-Site? | Yes |
Can store drugs? | Yes |
Has min/max thermometer? | Yes |
Is locked/secured? | Yes |
Has access to -70C freezer? | Yes |
Can store specimens? | Yes |
Min/Max thermometer has alarm? | Yes |
Log type? | Automatic |
-20C Freezer
Has -20C Freezer On-Site? | Yes |
Can store specimens? | Yes |
Min/Max thermometer has alarm? | Yes |
Log type? | Automatic |
Can store drugs? | Yes |
Has min/max thermometer? | Yes |
Is locked/secured? | Yes |
Refrigerator
Has refrigerator On-Site? | Yes |
Can store specimens? | Yes |
Min/Max thermometer has alarm? | Yes |
Log type? | Automatic |
Can store drugs? | Yes |
Has min/max thermometer? | Yes |
Is locked/secured? | Yes |
Who is notified in case of electrical outage, and how?
Pharmacy staff alerted by phone call |
DRUG STORAGE, HANDLING, & ACCOUNTABILITY
-70C Freezer
Has -70C Freezer On-Site? | Yes |
Can store drugs? | Yes |
Has min/max thermometer? | Yes |
Is locked/secured? | Yes |
Has access to -70C freezer? | Yes |
Can store specimens? | Yes |
Min/Max thermometer has alarm? | Yes |
Log type? | Automatic |
-20C Freezer
Has -20C Freezer On-Site? | Yes |
Can store specimens? | Yes |
Min/Max thermometer has alarm? | Yes |
Log type? | Automatic |
Can store drugs? | Yes |
Has min/max thermometer? | Yes |
Is locked/secured? | Yes |
Refrigerator
Has refrigerator On-Site? | Yes |
Can store specimens? | Yes |
Min/Max thermometer has alarm? | Yes |
Log type? | Automatic |
Can store drugs? | Yes |
Has min/max thermometer? | Yes |
Is locked/secured? | Yes |
Who is notified in case of electrical outage, and how?
Pharmacy staff alerted by phone call |
SITE LABORATORIES
Do you have access to tumor samples? | Yes |
Does the site have experience with tumor sample collection? | Yes |
Labs Currently Used
Name | Address | City | State | Zip |
|---|---|---|---|---|
Hospital Oncológico, Puerto Rico Medical Center | 1st Floor Gastroenterology Unit, Barrio Monacillos | Río Piedras | PR | 00935 |
Laboratorio Clínico Borinquen | Calle Dr Goyco Esq Baldorioty | Caguas | PR | 00725 |
Hato Rey Pathology Associates/HRP Labs | Avenida Domenech 300 | Hato Rey | PR | 00918 |
SITE LABORATORIES
Do you have access to tumor samples? | Yes |
Does the site have experience with tumor sample collection? | Yes |
Labs Currently Used
Hospital Oncológico, Puerto Rico Medical Center 1st Floor Gastroenterology Unit, Barrio Monacillos Río Piedras, PR, 00935 |
Laboratorio Clínico Borinquen Calle Dr Goyco Esq Baldorioty Caguas, PR, 00725 |
Hato Rey Pathology Associates/HRP Labs Avenida Domenech 300 Hato Rey, PR, 00918 |
FACILITIES
Radiology
CT | On-Site |
XRay | On-Site |
PET | Available |
MRI | On-Site |
Nuclear Medicine | On-Site |
Pharmacokinetic Sampling Capability
Single Sample | Yes |
24hrs | Yes |
10hrs | Yes |
Other
12-lead ECG | On-Site |
Research Pharmacy | On-Site |
Can work with IBC | Yes |
Sterile Drug Prep Hood | On-Site |
Unblinded Investigator | On-Site |
FACILITIES
Radiology
CT | On-Site |
XRay | On-Site |
PET | Available |
MRI | On-Site |
Nuclear Medicine | On-Site |
Pharmacokinetic Sampling Capability
Single Sample | Yes |
24hrs | Yes |
10hrs | Yes |
Other
12-lead ECG | On-Site |
Research Pharmacy | On-Site |
Can work with IBC | Yes |
Sterile Drug Prep Hood | On-Site |
Unblinded Investigator | On-Site |